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A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

Status
Active
Cancer Type
Lymphoma
Skin Cancer (Non-Melanoma)
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT01871727
Protocol IDs
E7777-G000-302 (primary)
NCI-2013-00713
Study Sponsor
Eisai Inc

Summary

The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in dose-finding part will be used to determine the dose of E7777 that should be used to test efficacy and safety.

Objectives

This is a multicenter, open-label, single-arm study of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL). The study will consist of an initial lead-in phase (in which a dose of E7777 will be selected), followed by the Main Study. Participants will move through three phases while on study: Pretreatment Phase, Treatment Phase, and Extension Phase and a Follow-up Period.
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